Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients

CAPTURE is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the Vine™ permanent carotid filter. The trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. All enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.

Inclusion criteria

• Atrial fibrillation (AF): documented persistent or permanent
• CHA2DS2-VASc score ≥ 4
• Age > 50
• Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
• Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
• CCA accessibility: up to 60mm from skin to CCA center, safe approach
• Patient is willing to provide informed consent
• Patient is willing to complete all scheduled follow-up

Exclusion criteria

• Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)
• Evidence of any atherosclerotic disease in CCA above the clavicles
• Evidence of carotid dissection
• Pre-existing stent(s) in CCA
• Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
• Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
• Female who is pregnant or who is planning to become pregnant during the course of the study
• Life expectancy of less than 1 year
• Active systemic infection
• Known sensitivity to nickel or titanium metals, or their alloys
• Known hereditary or acquired coagulation disorders
• Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure
• A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
• Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
• Active participation in another investigational drug or device treatment study
• Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study